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Active filter:Manufacturer SRN:KR-MF-000015840

34 device results listed.

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QDx A1c Advance Test kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660729
Basic UDI-DI: B-08806134660729
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE A1c Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660712
Basic UDI-DI: B-08806134660712
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA W COVID-19 Ag External Control Swab

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134656319
Basic UDI-DI: B-08806134656319
Reference: 563G
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

Greencare Flu 2 Influenza A&B Ag

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134616016
Basic UDI-DI: B-08806134616016
Reference: 161G
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA Multi Influenza Ag Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134615217
Basic UDI-DI: B-08806134615217
Reference: 152GS10
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA W COVID-19 Ag

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134601081
Basic UDI-DI: B-08806134601081
Reference: 643K
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA W COVID-19 Ag

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134601074
Basic UDI-DI: B-08806134601074
Reference: 643K
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA W COVID-19 Ag

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134601067
Basic UDI-DI: B-08806134601067
Reference: 643K
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA W COVID-19 Ag

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134601050
Basic UDI-DI: B-08806134601050
Reference: 643K
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIA W COVID-19 Ag

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134601043
Basic UDI-DI: B-08806134601043
Reference: 643K
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

QDx A1c Advance

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660620
Basic UDI-DI: 88061346A1CAKV
Reference: RT100M10
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem A1c Advanced

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660644
Basic UDI-DI: 88061346A1CAKV
Reference: 107032
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Performa A1c Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660668
Basic UDI-DI: 88061346A1CAKV
Reference: RT100M12
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 23.06.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE A1c Hemoglobin A1c Test Kit

IVD generalNot specifiedOn the market

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: D-KR-MF-000015840BS
Basic UDI-DI: B-KR-MF-000015840BS
Reference: RT100S10
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.06.2026 01:58

Manufacturer products Authorised representative products Authorised representative actors View details